The FDA’s committee recommended the Novavax vaccine for use in the U.S. on Tuesday.
FDA authorization would allow Novavax to start shipping doses to the U.S. from its manufacturing partner Serum Institute of India. However, the Centers for Disease Control and Prevention would still need to sign off on the vaccine before pharmacies and other health-care providers could start administering the shots.
Novavax asked the FDA to authorize its two-dose vaccine in late January. Dr. Doran Fink, a senior official at the FDA's vaccine division, told CDC advisors in April that reviewing Novavax's application has been"incredibly complex" because it involves clinical and manufacturing data.
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